The vast majority (93% as of December 2022) of the MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. While affected devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and corrected devices is a silicone foam. (, On June 14, 2021,Royal Philips subsidiary, Philips Respironics, initiated a voluntary recall notification, Repair and Replacement, Testing and Program Management, The Respironics recall remains highestpriority, Takingthe learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips, Extensive patient,clinicianand regulator engagement, ~90%production and 80% shipment ofrecall units in 2022, Encouraging test results forDreamStation1 devices, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken, Please click here for the latest testing results and updates, Summary of third-partyepidemiological studies, showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices, [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (, Regulatory and legal update - Civil litigation, Frequently Asked Questions and key materials, Respironics field action - FAQ - January 30, 2023, Summary of a systematic literature review of PAP device use and cancer risk - July 25, 2022, Third party epidemiological studies - FAQ related to the Swedish Study by Palm et al. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. If you have not received a copy of the notice and would like to see it, you can find a copy by clicking the link above. Are there any steps that customers, patients, and/or users should take regarding this issue? Contact your clinical care team to determine if a loan device is required. Updating everyone on what they need to know and do, and to participate in the corrective action. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. This could affect the prescribed therapy. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. Royal Philips (NYSE: PHG) is promising a turnaround from its bottom-line woes, which began with one of the largest medical devices recalls in recent history. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Go to www.philips.com/src-update and click on "Begin registration process" (For further information, you can also scroll down to the "Patient, Users, or Caregivers" heading and then click on "Begin registration process") Select your user or customer category and choose "Australia" as the country (even if you purchased your device overseas) Philips CPAP Recall Information. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance You can access the Philips RS North America webpage by clicking here. Patients who are concerned should check to see if their device is affected by the corrective action. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. If you do not have this letter, please call the number below. Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. The recall notification(U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. Only machines with serial numbers identified in the companys communications are affected by this recall. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. What is the safety hazard associated with this issue? Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. The following updates in relation to device testing have been released by Philips RS North America on this webpage: Please note that the Philips RS North America website also contains information specific to the CPAP, BiPAP and mechanical ventilator device recall in the USA, which may be different to and not relevant for Australia. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. 4. Click here to view a Notice from the Federal Court of Australia advising Group Members of the proposed discontinuance of a class action commenced by Mr Peter Lewis, represented by Carbone Lawyers, against Philips in relation to certain CPAP, Bi-PAP and mechanical ventilators. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. Theremediation of this field safety notice is underway and has started for the following devices: DreamStationCPAPs DreamStationBiPAPs DreamStationST/AVAPS Philips aims to address allaffected devices within the scope of this field safety notice but due to thevolume of devices that have been affected, we regret it may take some time torepair or replace patients' devices. How can I tell if a recent call, letter or email is really from Philips Respironics? To register your product, you'll need to log into you're my Philips account. As a result of extensive ongoing review, on June 14, 2021, Philips voluntarily decided to issue a global recall notification related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. Should affected devices be removed from service? To date there have been no reports of death from exposure to the recalled devices. Based on the particle size analysis, the bacterial filter will effectively filter out any foam particulate that could make its way up the patient circuit. All rights reserved. We thank you for your patience as we work to restore your trust. 2) the PE-PUR foam may off-gas certain chemicals. Philips Australia expects to have completed the replacement program by the end of 2022 for the majority of devices where, by 12 December 2022, patients (1) registered a device type listed below; and (2) provided their device settings preference to Philips. Process Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers The FDA acknowledges that the submission of anMDRitself is not evidence that the device caused or contributed to the adverse outcome or event and that the cause of an event cannot typically be determined from this reporting system alone. Background Following Philips public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Is there any possibility others are affected? The FDA has identified this as a Class I recall, the most serious type of recall. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Consult your Instructions for Use for guidance on installation. Don't have one? As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. However, this new recall does apply to some of the devices recalled . Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. Philips may work with new patients to provide potential alternate devices. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. At this time, affected devices are on manufacturing and ship hold. Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution. We thank you for your patience as we work to restore your trust. The contacts included Durable Medical Equipment (DME) suppliers. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). We thank you for your patience as we work to restore your trust. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US Philips Australia will work with your clinical care team to arrange a loan device, where required. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. For more information on the recall notification (U.S. only) / field safety notice (International Markets), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. Philips has established a registration process that allows Patients, Users, or Caregivers to look up their device serial number and begin a claim if their unit is affected. Additionally, daily cleaning of the mask and tubing may remove trapped particles and increase the odds of detection. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023 In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. We are in touch with relevant customers and patients. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? Stopping treatment suddenly could have an immediate and detrimental effect on patient health. . You are about to visit a Philips global content page. All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. The recall includes many mechanical ventilator . We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options. The company has developed a comprehensive plan for this correction, and has already begun this process. Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. The FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue. On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. 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